FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
4249–4272 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 04, 1998
T-UPTAKE MICROPLATE EIA
K980088 · KHQ
Monobind
Chemistry · 26d
Cleared Feb 02, 1998
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
K974027 · CDP
Alfa Biotech (Uk) , Ltd.
Chemistry · 102d
Cleared Feb 02, 1998
DBEST ONE-STEP OVULATION TEST
K974508 · CEP
Ameritek, Inc.
Chemistry · 63d
Cleared Feb 02, 1998
RANDOX CALCIUM
K974607 · CJY
Randox Laboratories, Ltd.
Chemistry · 54d
Cleared Feb 02, 1998
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
K980028 · CKA
Trace America, Inc.
Chemistry · 28d
Cleared Jan 30, 1998
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
K974825 · JIX
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Jan 30, 1998
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30
K974858 · CEO
Diagnostic Chemicals , Ltd.
Chemistry · 32d
Cleared Jan 30, 1998
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION...
K980030 · CIT
Trace America, Inc.
Chemistry · 25d
Cleared Jan 28, 1998
STAT TRACKS
K974762 · JJQ
Awareness Technology, Inc.
Chemistry · 40d
Cleared Jan 28, 1998
CARESIDE GLOBULIN
K980055 · JGE
Exigent Diagnostics, Inc.
Chemistry · 22d
Cleared Jan 28, 1998
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
K980135 · JJS
Radiometer America, Inc.
Chemistry · 13d
Cleared Jan 26, 1998
PYRILINKS-D ASSAY KIT
K974260 · JMM
Metra Biosystems, Inc.
Chemistry · 74d
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451 · CGA
Lifescan, Inc.
Chemistry · 62d
Cleared Jan 26, 1998
QUICKSTICK PRO HCG TEST
K974615 · JHI
Phamatech
Chemistry · 46d
Cleared Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · LBR
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · LCX
Quidel Corp.
Chemistry · 34d
Cleared Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM...
K972669 · CGA
Polymer Technology Systems, Inc.
Chemistry · 190d
Cleared Jan 22, 1998
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
K974822 · JJY
Avl Scientific Corp.
Chemistry · 29d
Cleared Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
K974826 · JJY
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Jan 22, 1998
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
K974851 · JHI
San Diego Biotech
Chemistry · 24d
Cleared Jan 22, 1998
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · CFJ
Diagnostic Chemicals , Ltd.
Chemistry · 24d
Cleared Jan 16, 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818 · MMI
Radiometer America, Inc.
Chemistry · 24d
Cleared Jan 13, 1998
TRIAGE STATMETER
K973547 · KHO
Biosite Incorporated
Chemistry · 117d
Cleared Jan 13, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K974644 · JJX
Johnson & Johnson Clinical...
Chemistry · 32d